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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 100 03 12 000
Date submitted: 3/25/2012
Manufacturer:Covidien
Device Type:Kendall Monoject Syringes - Toomey Tip 60 ml 8881560265
Description:Syringes, Single use devices
Medical Device Identifier:Toomey Tip 60 ml 8881560265 ref no AT-2009-08-20-004 Lot/batch no.: All
Reason of Field Safety Corrective Action:The outer packaging consists of a hard plastic housing sealed by spot welding. The warning is that the package does not hold a sterile barrier, especially against airborne microorganisms. When exposed to alternating pressure conditions, vibration or other conditions in the environment, there is no barrier against airborne particles or microorganisms
Remedy Action:The product Kendall Monoject Syringe - Toomey Tip 60 ml does not conform to the essential requirements of MDD 93/42/EEC, annex 1, section 1, 8.1, and 8.3. The MPA therefore estimates that the products are not properly labeled as sterile and should be recalled from the market by the manufacturer
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCAR
Source Ref. Number:SE-2012-03-19-010
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments